Shots:
Genentech has reported the P-III trials results, incl. FENhance 2 study assessing fenebrutinib (PO) vs teriflunomide in 1,497 adults with RMS for ~96wks.
Trial met its 1EP of reduced annualized relapse rate over ~96wks. with favorable liver safety; additional safety data will be further evaluated; data to be presented in future meeting, along with…
Shots:
Genentech has reported the P-III (ALLEGORY) trial data assessing Gazyva vs PBO in ~300 adults with SLE on SoC for 52wks. followed by ~104wks. OLE period
Trial met its 1EP, with more participants achieving ≥4-point improvement in SRI-4 at 1yr., & achieved all key 2EPs, incl. improved BICLA response & a 6-point SRI-6 improvement at…
Shots:
Ventus Therapeutics has entered a multi-year collaboration with Genentech to discover and optimize novel small-molecule drugs for major diseases using its ReSOLVE platform
As per the deal, Ventus will utilize its ReSOLVE platform to identify small-molecule leads for multiple targets, while Genentech will be responsible for preclinical, clinical, and commercial development. Ventus will receive…
Shots:
The US FDA has approved Gazyva (4 initial dose then Q6M) for the treatment of adults with lupus nephritis who are on SoC & also allowing a shorter 90min. infusion after the first dose for eligible pts
Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved…
Shots:
Starpharma has entered into a collaboration & license agreement with Genentech to develop dendrimer-drug conjugates incorporating Genentech’s drugs for oncology targets, leveraging Starpharma’s DEP drug delivery tech
As per the deal, Genentech will receive an exclusive global license under Starpharma’s IP to develop & commercialize collaboration-derived products, potentially multiple per target, in exchange for…
Shots:
Genentech has reported new data from the open-label AVONELLE-X & P-IIIb/IV (SALWEEN) studies of Vabysmo (faricimab-svoa) at Euretina’25
The 2yr. AVONELLE-X study was an extension of P-III (TENAYA & LUCERNE) trials, showing maintained vision & anatomy in wet AMD, with ~80% pts extending dosing to Q3M/Q4M after ~4yrs. of therapy
SALWEEN study in Asia…
OMass has entered into an exclusive collaboration & license deal with Genentech to develop & commercialize its preclinical oral small molecule program for inflammatory bowel disease
As per the deal, OMass will receive $20M upfront & over $400M in preclinical, development, commercial, & sales milestones, with tiered royalties based on net sales
Collaboration leverages OMass’…
Shots:
Genentech has reported 96wk. data from P-II (FENopta) trial assessing fenebrutinib vs PBO for 12wks. in 109 RMS pts (18-55yrs.); 99 pts then opted for a 192wk. OLE study, with 93 remaining after 96wks.
OLE study showed sustained efficacy over 96wks. with a low ARR of 0.06, no disability progression (per EDSS) & no…
Shots:
Genentech has reported 2yr. P-III (STARGLO) trial data assessing Columvi + GemOx vs Rituxan + GemOx in previously treated ASCT-ineligible r/r DLBCL pts
At 24.7mos. mFU, trial showed a 40% improvement in OS (mOS: not reached vs 13.5mos.), a 59% reduction in risk of progression or death, & CRs in 58.5% vs 25.3% pts;…
Shots:
Genentech has entered into a multi-year collaboration with Orionis to discover small-molecule monovalent glue drugs for novel & difficult oncology targets using Orionis’ Allo-Glue platform
As per the deal, Orionis will receive $105M upfront & ~$2B in research, development, commercial, & sales milestones, with tiered royalties; Orionis will lead discovery & optimization, while Genentech…

